Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Biologic License Application (BLA): 125288
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NULOJIX BELATACEPT 250MG INJECTABLE; INJECTION Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/15/2011 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125288s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125288s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125288Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2018 SUPPL-75 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125288s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125288Orig1s075ltr.pdf
11/09/2017 SUPPL-74 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125288Orig1s074ltr.pdf
05/09/2017 SUPPL-72 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125288Orig1s072ltr.pdf
02/02/2017 SUPPL-70 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125288Orig1s070ltr.pdf
09/30/2014 SUPPL-62 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125288Orig1s062ltr.pdf
04/15/2014 SUPPL-59 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125288Orig1s059ltr.pdf
04/08/2013 SUPPL-30 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125288s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125288Orig1s030ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/13/2018 SUPPL-75 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125288s075lbl.pdf
11/09/2017 SUPPL-74 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s074lbl.pdf
11/09/2017 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s074lbl.pdf
02/02/2017 SUPPL-70 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125288s070lbl.pdf
09/30/2014 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s062lbl.pdf
04/15/2014 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125288s059lbl.pdf
04/08/2013 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125288s030lbl.pdf
06/15/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125288s0000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English